DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container...

FDA Device Recall #Z-2319-2013 — Class II — March 7, 2013

Recall Summary

Recall Number Z-2319-2013
Classification Class II — Moderate risk
Date Initiated March 7, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm DeVilbiss Healthcare LLC
Location Somerset, PA
Product Type Devices
Quantity 112,849

Product Description

DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.

Reason for Recall

End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable.

Distribution Pattern

Worldwide Distribution - USA and the countries of Mexico and Canada.

Lot / Code Information

Part Number 7305D-634 with model numbers 7305D-632, 7305D-633, and 7305D-633-25

Other Recalls from DeVilbiss Healthcare LLC

Recall # Classification Product Date
Z-1558-2023 Class II DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENT... Mar 9, 2023
Z-0724-2023 Class II DeVilbiss, 525 5-liter Oxygen Concentrator Mod... Nov 18, 2022
Z-0229-2023 Class II 125 series iGO2 Portable Oxygen Concentrator-in... Sep 19, 2022
Z-2246-2016 Class II DeVilbiss Model 7305P-D Powered Suction Unit May 23, 2016
Z-1949-2014 Class III DeVilbiss Model DV5x Series CPAP units. For use... May 13, 2014

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.